NCT06888154

Brief Summary

This study aims to evaluate the effect of hot compress application to the intestines during abdominal surgery on postoperative nausea-vomiting and bowel function. Volunteers will be randomly assigned to the intervention and control groups. Initially, 30 patients will be included in each group, and the study will be completed based on the effect size determined by power analysis. Hypotheses: H0: Covering the intestines with saline heated at 36°C during surgery has no effect on postoperative nausea and vomiting. H1: Covering the intestines with saline heated at 36°C during surgery affects postoperative nausea and vomiting. H01: Covering the intestines with saline heated at 36°C during surgery has no effect on postoperative bowel function. H11: Covering the intestines with saline heated at 36°C during surgery affects postoperative bowel function. Inclusion Criteria: Undergoing abdominal surgery in the general surgery ward, Aged 18 years or older, Having a BMI between 18.50-24.99 kg/m², Able to communicate verbally, Willing to participate in the study, Conscious and oriented patients. Exclusion Criteria: History of previous gastrointestinal surgery, Postoperative complications, History of small bowel resection, ileostomy, or colostomy, History of emergency surgery, neoadjuvant therapy, appendectomy, or inflammatory bowel disease, Chronic opioid use, Chronic constipation (≤ 2 bowel movements per week), History of abdominal radiotherapy, Admission to the intensive care unit or postoperative bleeding. Application: Intervention Group: Routine preoperative procedures will be performed. During surgery, the intestines will be covered with sterile gauze soaked in saline heated at 36°C to prevent drying and reduce the risk of infection. Routine postoperative procedures will also be applied. Control Group: Routine preoperative, intraoperative, and postoperative procedures will be applied. During surgery, the intestines will be covered with sterile gauze soaked in unheated saline, following standard practice. Outcome Measures: Primary Outcome: Gastrointestinal function assessment index, including time to first flatulence, first defecation, first normal bowel sounds, and first consumption of liquid/semi-solid food. Secondary Outcome: Gastrointestinal symptoms such as nausea, abdominal bloating, pain, and vomiting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

March 9, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

abdominal surgeryhot compressoperating roomnursing

Outcome Measures

Primary Outcomes (1)

  • will be an index of gastrointestinal functional assessment, including time to first passing gas, first defecation, first normal bowel sounds and first consumption of liquid/semi-general diet foods

    Quality of Recovery-15 (QoR-15) Scale Scores: The QoR-15 scale is a validated tool used to assess postoperative recovery quality. It consists of 15 items, each scored on a 0-10 scale, with a total score range of 0 to 150 (higher scores indicate better recovery). Scoring Interpretation: 0 - 70 → Poor recovery 71 - 100 → Moderate recovery 101 - 150 → Good recovery Gastrointestinal Symptom Rating Scale (GSRS) - Scale Scores The Gastrointestinal Symptom Rating Scale (GSRS) is a validated tool used to assess the severity of gastrointestinal (GI) symptoms. It consists of 15 items, each scored on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort). Scoring Interpretation: Total Score Range: 15 to 105 (higher scores indicate worse GI symptoms). Mean score calculation: Total score is divided by the number of items (15) to determine the severity of symptoms. Interpretation of Scores: 15 - 30 → Mild symptoms 31 - 60 → Moderate symptoms 61 - 105 → Severe symptoms

    postoperative 1-3 day

Study Arms (2)

Intervention Group (Hot compress Application)

EXPERIMENTAL

Patients in this group will be toweled with heated saline during abdominal surgery. After the abdomen is opened, the intestines will be covered with a sterile towel soaked in saline heated to 36°C to prevent drying and reduce the risk of infection.

Other: compress application with heated saline

Control Group (Routine Care)

NO INTERVENTION

Patients in this group will receive standard surgical care.

Interventions

Covering intestines with sterile gauze soaked in 36°C heated saline during surgery to prevent drying and reduce infection risk

Intervention Group (Hot compress Application)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Abdominal surgery in the general surgery ward
  • years of age or older
  • Patients with BMI in the normal range (18.50-24.99 kg/m2)
  • Able to communicate verbally
  • Those who volunteered to participate in the study
  • Patients with no mental confusion, conscious and oriented will be included.

You may not qualify if:

  • Previous gastrointestinal system surgery
  • Complications in the postoperative period
  • History of small bowel resection and ileostomy or colostomy
  • Surgical history of inflammatory bowel diseases, emergency surgery, neoadjuvant therapy, appendectomy,
  • Chronic opioid use,
  • Experiencing chronic constipation (≤ 2 bowel movements per week),
  • Abdominal radiotherapy
  • Patients admitted to intensive care unit and patients with bleeding will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Merkez, Kırşehir, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Dilek TALHAOĞLU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 21, 2025

Study Start

May 15, 2025

Primary Completion

February 15, 2026

Study Completion

February 25, 2026

Last Updated

October 6, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations